Mylan Inc. announced that its subsidiary, Mylan Pharmaceuticals Inc., has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for venlafaxine hydrochloride (HCl) tablets 25 mg (base), 37.5 mg (base), 50 mg (base), 75 mg (base) and 100 mg (base).
Venlafaxine HCl tablets, indicated for the treatment of major depressive disorder, are the generic version of Wyeth's Effexor tablets, which had annual US sales of approximately $188 million for the 12 months ending March 31, 2008.
The Company planning to ship Venlafaxine HCl immediately. Currently, Mylan has 92 ANDAs pending FDA approval, 20 of which are potential first-to-file opportunities. Mylan Inc., with a presence in more than 90 countries, ranks among the leading diversified generic and specialty pharmaceutical companies in the world. The company maintains one of the industry's broadest – and highest quality – product portfolios, supported by a robust product pipeline; owns a controlling interest in the world's second largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies.